risk of re-hospitalization in patients with chronic obstructive pulmonary disease (copd) post exacerbation

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this retrospective database study will assess differences in the risk of re-hospitalization and other copd-related exacerbations and costs for patients receiving fluticasone propionate/salmeterol xinafoate combination 250/50 (fsc) versus anticholinergics \[i.e. tiotropium (tio) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium - ipr)\] post-hospitalization or emergency department (ed) visit for the treatment of copd. this is a hypotheses testing study. associations are compared between fsc and ac cohorts. hypotheses for the primary outcome and key secondary outcomes are presented below: specifically the study hypotheses for the primary outcome being tested were: ho: there is no difference in risk of copd-related hospitalization between fsc and ac ha: there is a difference in risk of copd-related hospitalization between fsc and ac hypothesis for the key secondary outcome of copd-related costs that was tested was: ho: there is no difference in copd-related costs between fsc and ac ha: there is a difference in copd-related costs between fsc and ac

managed care patients (aged \>40 years) who were fluticasone propionate/salmeterol xinafoate combination (fsc)-naive in the 12 months pre-index period. the index-date was the date of discharge of the index chronic obstructive pulmonary disease (copd)-related hospitalization/emergency department (ed) visit. eligible patients were required to newly initiate or switch to drug therapy with fsc or ipratropium (ipr) / tiotropium (tio) during the identification period (01/01/2004 to 01/31/2008) to treat copd. patients who switched to another maintenance medication or had an exacerbation in the treatment assessment period (30-days post-index date) were excluded from the study. follow-up period was 12 months post treatment assessment period. patients classified as being on fsc 250/50 versus anticholinergics (tio, ip or ipr). examined risk of copd-related exacerbations such as hospitalizations, emergency department (ed) visits, copd-related physician/outpatient visit with oral corticosteroid (ocs) or antibiotic prescription (abx) within 5 days of physician/outpatient visit and copd-related medical, pharmacy, and total healthcare costs in follow-up period.

Eligibility criteria:
inclusion criteria: * ≥40 years of age at index discharge date * continuous health plan eligibility in the pre-index, treatment assessment, and follow-up periods * absence of other fluticasone propionate -salmeterol xinafoate doses or combination product of budesonide-formoterol anytime during pre-index, treatment assessment, and follow-up periods exclusion criteria: * copd-related exacerbation during the treatment assessment period * any therapy change, which was defined as switching or augmenting index therapy during treatment assessment period * absence of comorbid conditions (respiratory cancer, cystic fibrosis, fibrosis due to tuberculosis, bronchiectasis, pneumonociosis, pulmonary fibrosis, pulmonary tuberculosis, and sarcoidosis) during the pre-index, treatment assessment, and follow-up periods